NCT04033289已完成不适用
The Clinical Efficacy of Hip Protection Orthosis for The Protection of Hip Dislocation in Patients With Severe Cerebral Palsy, Single Blinded, Randomized-control Trial, Multicenter Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Migration index
研究概览
简要总结
Single Blinded, Randomized-control tiral, Multicenter clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GMFCE level IV or V in the Cerebral palsy
- •age from 1 to 10
排除标准
- •History of hip joint surgery
- •Botulinum toxin injection to hip muscle past 3 months or expected in our study duration
研究组 & 干预措施
control group
No Intervention
experimental group
Experimental
干预措施: Hip protection orthosis (Device)
结局指标
主要结局
Migration index
时间窗: 6 months
Hip AP radiography
次要结局
- Cobb's angle (')(6 months)
- Child Health Index of Life with Disabilities (CPCHILD)(6 months)
- Range of motion of hip joint (')(6 months)
- Visual analog scale(6 months)
- Likert scale (score)(immediately after wearing orthosis)
研究者
Ju Seok Ryu
Professor
Seoul National University Hospital
研究点 (1)
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